Irrigation/Urology Sets— 510(k) K254111
Substantially EquivalentB.Braun Medical, Inc.
FDA 510(k) clearance K254111 for Irrigation/Urology Sets, Substantially Equivalent on 2026-09-10. Applicant: B.Braun Medical, Inc.. Device class: 2.
Summary
B. Braun's Irrigation/Urology Sets are filed under LJH, urological irrigation systems.
Class II, 21 CFR 876.5130. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
B. Braun Medical filed from Center Valley, Pennsylvania. Review took 265 days (December 19, 2025 to September 10, 2026). The record doesn't list the individual set configurations.
Clearance details
- Applicant
- B.Braun Medical, Inc.
- Product code
- Product code LJH
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.